Esophageal Temperature During PVI Using Q-DOT Micro

NCT06392932 | Recruiting FDA Device

• 1 other identifier: STUDY00002707
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess how two different ablation strategies, using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation, affect the temperature of the esophagus during ablation, and the risk of injury to the esophagus.

Conditions

Atrial Fibrillation Paroxysmal

Keywords

Atrial Fibrillation; Esophageal thermal injury

Outcome Measures

Primary Outcomes (1)

• Maximal change in esophageal temperature during posterior wall isolation.

  During ablation procedure.

Secondary Outcomes (2)

• Presence of esophageal thermal injury seen on post-procedure capsule endoscopy.

  2-4 days after ablation procedure.

• Presence of procedural complications.

  During and immediately following ablation procedure.

Other Outcomes (4)

• Number of RF ablation lesions to performed pulmonary vein isolation.

  During ablation procedure.

• RF time during pulmonary vein isolation.

  During ablation procedure.

• Left atrial dwell time to achieve pulmonary vein isolation.

  During ablation procedure.

Study Arms (2)

QDOT Arm

EXPERIMENTAL

Temperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter.

Device: QDOT Micro ablation catheter

ST SF Arm

ACTIVE COMPARATOR

Conventional high-power short-duration ablation using the ThermoCool ST SF catheter.

Device: ST SF ablation catheter

Interventions

QDOT Micro ablation catheter DEVICE

QDOT Micro ablation catheter

QDOT Arm

ST SF ablation catheter DEVICE

ST SF ablation catheter

ST SF Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged greater than or equal to 18 years
• Diagnosed with paroxysmal atrial fibrillation
• Undergoing RF catheter ablation for treatment of paroxysmal atrial fibrillation that will involve circumferential point-by-point radiofrequency ablation pulmonary vein isolation with no additional left atrial posterior wall ablation planned

You may not qualify if:

• Patients who have undergone prior left atrial ablation procedures.
• Patients where the use of the Q-DOT Micro ablation catheter in QMODE+ (i.e. temperature-controlled very-high-power short-duration ablation) is felt to be unsafe.
• Patients who have contraindications to capsule endoscopy, or GI conditions that may increase the risks of capsule endoscopy (e.g. esophageal strictures, inflammatory bowel disease, etc)
• Any records flagged "break the glass" or "research opt out."

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Cedars-Sinai Smidt Heart Institute

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eric D Braunstein, MD

CONTACT

310-248-6679; Eric.Braunstein@cshs.org

Tansy Aguilar

CONTACT

tansy.aguilar@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interpreters of the esophageal capsule endoscopy will be blinded to study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician I

Model Details: Prospective open-label randomized controlled trial

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)